TRANDATE

Trandate tablets should be taken orally with food.

Adults:

Hypertension Treatment should start with 100mg twice daily. In patients already being treated with antihypertensives and in those of low body weight this may be sufficient to control blood pressure. In others, increases in dose of 100mg twice daily should be made at fortnightly intervals.

Many patients’ blood pressure is controlled by 200mg twice daily and up to 800mg daily may be given as a twice daily regimen. In severe, refractory hypertension, daily doses up to 2400mg have been given. Such doses should be divided into a three or four times a day regimen.

Elderly In elderly patients, an initial dose of 50mg twice daily is recommended. This has provided satisfactory control in some cases. In the hypertension of pregnancy The initial dose of 100mg twice daily may be increased, if necessary, at weekly intervals by 100mg twice daily.

During the second and third trimester, the severity of the hypertension may require further dose titration to a three times daily regimen, ranging from 100mg tds to 400mg tds. A total daily dose of 2400mg should not be exceeded. Hospital in-patients with severe hypertension, particularly of pregnancy, may have daily increases in dosage.

General If rapid reduction of blood pressure is necessary, see the SPC for Trandate Injection. If long-term control of hypertension following the use of Trandate Injection is required, oral therapy with Trandate tablets should start with 100mg twice daily.

g. diuretics, methyldopa etc. When transferring patients from such agents, Trandate tablets should be introduced with a dosage of 100mg twice daily and the previous therapy gradually decreased. Abrupt withdrawal of clonidine or beta-blocking agents is undesirable.

Angina co-existing with hypertension In patients with angina pectoris co-existing with hypertension, the dose of Trandate will be that required to control the hypertension.

Children:

Safety and efficacy in children have not been established

Most side-effects are transient and occur during the first few weeks of treatment with Trandate.

They include:

Blood and the lymphatic system disorders Rare reports of positive antinuclear antibodies unassociated with disease, hyperkalaemia, particularly in patients who may have impaired renal excretion of potassium, thrombocytopenia. Psychiatric disorders Depressed mood and lethargy, hallucinations, psychoses, confusion, sleep disturbances, nightmares.

Nervous system disorders Headache, tiredness, dizziness, tremor has been reported in the treatment of hypertension of pregnancy. Eye disorders Impaired vision, dry eyes. Cardiac disorders Bradycardia, heart block, heart failure, hypotension Vascular disorders Ankle oedema, increase of an existing intermittent claudication, postural hypotension, cold or cyanotic extremities, Raynaud’s phenomenon, paraesthesia of the extremities.

Respiratory, thoracic and mediastinal disorders Bronchospasm (in patients with asthma or a history of asthma), nasal congestion, interstitial lung disease. Gastrointestinal disorders Epigastric pain, nausea, vomiting, diarrhoea. Hepato-biliary disorders Raised liver function tests, jaundice (both hepatocellular and cholestatic), hepatitis and hepatic necrosis.

Skin and subcutaneous tissue disorders Sweating, tingling sensation in the scalp, usually transient, may occur in a few patients early in treatment, reversible lichenoid rash, systemic lupus erythematosus, exacerbation of psoriasis.

Musculoskeletal, connective tissue and bone disorders:

Cramps, toxic myopathy. Renal and urinary disorders Acute retention of urine, difficulty in micturition. Reproductive system and breast disorders Ejaculatory failure. Nipple pain, Raynaud's phenomenon of the nipple (frequency not known) General disorders and administration site conditions Hypersensitivity (rash, pruritus, angioedema and dyspnoea), drug fever, masking of the symptoms of thyrotoxicosis or hypoglycaemia, reversible alopecia.

There have been reports of skin rashes and/ or dry eyes associated with the use of beta-adrenoceptor blocking drugs. The reported incidence is small and in most cases the symptoms have cleared when the treatment was withdrawn. Gradual discontinuance of the drug should be considered if any such reaction is not otherwise explicable.

The occurrence of intraoperative floppy iris syndrome (IFIS, a variation of Horner’s syndrome) has been observed during cataract surgeries in some patients who were being treated with tamsulosine, or have been treated with tamsulosine in the past.

IFIS has also been reported when other alpha-1-blockers were being used, and the possibility of a class effect cannot be excluded. Since IFIS can lead to a higher chance of complications during cataract surgeries, the ophthalmologist needs to be informed if alpha-1-blockers are currently being used, or have been used in the past.

There have been rare reports of severe hepatocellular injury with labetalol therapy. The hepatic injury is usually reversible and has occurred after both short and long term treatment. Appropriate laboratory testing should be done at the first sign or symptom of liver dysfunction.

If there is laboratory evidence of liver injury or the patient is jaundiced, labetalol therapy should be stopped and not re-started. Due to negative inotropic effects, special care should be taken with patients whose cardiac reserve is poor and heart failure should be controlled before starting Trandate therapy.

Patients particularly those with ischemic heart disease, should not interrupt/discontinue abruptly Trandate therapy. e. over 1-2 weeks, if necessary at the same time initiating replacement therapy, to prevent exacerbation of angina pectoris.

In addition, hypertension and arrhythmias may develop. It is not necessary to discontinue Trandate therapy in patients requiring anaesthesia but the anaesthetist must be informed and the patient should be given intravenous atropine prior to induction.

• Cardiogenic shock. • Uncontrolled, incipient or digitalis-refractory heart failure. • Sick sinus syndrome (including sino-atrial block). • Second or third degree heart block. • Prinzmetal’s angina. • History of wheezing or asthma. • Untreated phaeochromocytoma.

• Metabolic acidosis. • Bradycardia (<45-50 bpm). • Hypotension. • Hypersensitivity to labetalol. • Severe peripheral circulatory disturbances.